中国医药子公司天方药业达比加群酯胶囊两款规格获药品注册证书

Core Viewpoint - China National Pharmaceutical Group Co., Ltd. announced that its wholly-owned subsidiary, Tianfang Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the registration of Dabigatran Etexilate Capsules, which will enhance the company's product line and development experience in generic drugs [1] Group 1: Product Approval and Specifications - The approved drug includes two specifications: 110mg and 150mg [1] - The drug is primarily used for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as for the treatment and prevention of deep vein thrombosis and pulmonary embolism [1] Group 2: Financial and Market Impact - The drug registration application was accepted in May 2024, with a total investment of approximately 28 million RMB [1] - According to data from Minet, the estimated sales revenue for the drug in China's three major terminal markets in 2024 is approximately 571 million RMB [1] Group 3: Competitive Landscape and Future Outlook - Currently, there are 14 manufacturers, including Tianfang Pharmaceutical, that have obtained approval for this drug in China [1] - The company indicated that future sales may be influenced by national policies and market conditions, which could lead to performance that does not meet expectations [1]